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Recruiting NCT07172295

Modulate Tremor Severity With Low-intensity Focused Ultrasound Stimulation Targeting the Deep Nucleus of Patients With Refractory Hand Tremor.

No phase Interventional Parkinson Disease (PD) Essential Tremor Dystonic Tremor Continuous Theta Burst Stimulation Transcranial Focused Ultrasound

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Accelerated NaviFUS-ctbFUS stimulation.
Who it may be relevant to
Registry conditions: Parkinson Disease (PD), Essential Tremor, Dystonic Tremor, Continuous Theta Burst Stimulation Transcranial Focused Ultrasound. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The study plans to recruit 12 patients with Parkinsonian tremor, essential tremor, or dystonic tremor. After receiving NaviFUS-ctbTUS stimulation, the improvement in their tremor will be recorded.

Interventions

  • Procedure Accelerated NaviFUS-ctbFUS stimulation
    Three consecutive sessions of NaviFUS-ctbTUS stimulation were performed, with a 5-minute interval between each session. The acoustic pressure was set such that the estimated intracranial pressure at 30% skull transmission was approximately 0.5 MPa. The stimulation target was the center of the Vop, with a total of 7 stimulation points.

Primary outcome measures

  • Incidence of Adverse Events Compared to Baseline [Safety Assessment] [Time frame: Day of first stimulation, 7 days after first stimulation, day of second stimulation, 7 days after second stimulation, and 28 days after second stimulation.]
Secondary outcome measures (1)
  • Change in Tremor Amplitude [Efficacy] [Time frame: On the day of first stimulation and the day of second stimulation: immediately before treatment, and at 0, 20, 40, and 60 minutes post-treatment; on the day of second stimulation, also after task-based fMRI.]

Eligibility criteria

Inclusion criteria

  • Age between 18 and 80 years.
  • Subjects must belong to one of the following three categories:
  • Patients with Parkinson's disease tremor who have an inadequate response to medication.
  • Patients with essential tremor who have an inadequate response to medication.
  • Patients with dystonic tremor who have an inadequate response to medication.
  • Subjects are willing to shave hair over the treatment area for focused ultrasound.
  • Stable medication regimen (types and dosages) for at least 4 weeks prior to study enrollment.
  • Normal liver and renal function (Creatinine < 1.3 mg/dL, GPT < 41 U/L).
  • Female participants of childbearing potential, or male participants with female partners of childbearing potential, must agree to use appropriate contraception from the first study treatment until at least 6 months after the last treatment to prevent pregnancy.

Exclusion criteria

  • Presence of intracranial implants deemed unsuitable for MRI, such as metal clips, ventriculoperitoneal (VP) shunts, cochlear implants, deep brain stimulation (DBS) devices, pacemakers, or implantable cardioverter- defibrillators (ICDs).
  • Any abnormalities along the focused ultrasound beam path through the skull, including scars on the skull, scalp conditions (e.g., eczema), open wounds, calp atrophy, or significant calcification confirmed by imaging along the ultrasound transmission pathway.
  • Pregnant or breastfeeding women.
  • Use of investigational drugs from other clinical trials.
  • Patients with major depressive disorder (Beck Depression Inventory-II score > 30 within the past year) or with suicidal ideation.
  • Any condition that, in the opinion of the investigator, may interfere with treatment efficacy or increase risk to the subject.
  • Presence of any brain tumors, vascular malformations, or significant traumatic brain injury.
  • Presence of significant psychiatric symptoms (Clinical Dementia Rating \[CDR\]
  • 2).
  • Use of anticoagulant medications.
  • Use of medications known to exacerbate tremor.
  • Tremor due to metabolic or psychogenic causes.
  • Coagulopathy or abnormal coagulation profiles, including any of the following:
  • Platelet count ≤ 100,000/µL
  • INR ≥ 1.5
  • PT ≥ 1.5 × upper limit of normal (ULN)
  • aPTT ≥ 1.5 × ULN
  • Fibrinogen ≤ 150 mg/dL
  • Inability to provide informed consent or comply with study procedures, posing potential safety concerns.
  • Insufficient skull density as determined by pre-treatment evaluation, resulting in ultrasound transmission efficiency less than 20%.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • National Taiwan University Hospital Hsin-Chu Branch — Hsinchu

Identifiers

NCT: NCT07172295 · 202405134DINC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗